Herbal Medicine (Regulation)

Andrew Gwynne Excerpts

Tuesday 9th July 2013 Westminster Hall

[Andrew Gwynne (Denton and Reddish) (Lab)]

It is a pleasure to see you in the Chair, Mr Bone. I congratulate the hon. Member for Bosworth (David Tredinnick) on securing the debate. As someone who, over the past few days, has been suffering with quite bad hayfever, I would quite like a remedy, herbal or otherwise, for my suffering. I am pleased that we have had a chance in today’s debate to discuss some very important issues in relation to the regulation of herbal medicine. I know from the hon. Gentleman’s previous contributions in the House that he takes a very keen interest in and is a committed supporter of various forms of alternative medicine, including homeopathy and herbal medicine. He continues to raise these issues passionately in the House, most recently in the estimates day debate last week. I also congratulate the hon. Members for Strangford (Jim Shannon) and for Kettering (Mr Hollobone) and my hon. Friend the Member for Vauxhall (Kate Hoey) on echoing the many issues and problems. There are issues with the provision of non-manufactured herbal medicine due to the absence of regulation of herbal regulation practitioners. There have admittedly been delays in making progress on the regulations, which all relevant parties agree with, and all sides agree that the unexplained delays are frankly unacceptable. I will return to that later in my contribution.

As we know, the MHRA is responsible for medicines. It explains the licensing of manufactured herbal medicines as follows:

“The new European Traditional Herbal Medicinal Products Directive…came into effect on 30 April 2011. The Directive establishes a regulatory approval process for herbal medicines in the European Union...It requires each EU Member State to set up a traditional herbal registration scheme for manufactured traditional herbal medicines that are suitable for use without medical supervision. Companies are no longer able to sell manufactured unlicensed herbal medicines unless they have an appropriate product licence”.

The supply of non-manufactured medicines is permitted, but there remains a long-standing concern with the non-regulation of herbal medicine practitioners. Currently, anyone can set up as a practitioner. The guidance states:

“Regulation 3 of The Human Medicines Regulations 2012 (formally Section 12(1) of the Medicines Act 1968) is commonly referred to as the ‘herbalist exemption’ and permits unlicensed remedies to be made up and supplied by a practitioner to meet the needs of an individual patient following a one-to-one consultation. The existence of this regime is greatly valued by herbal practitioners and by many members of the public. However, there are widely acknowledged weaknesses in the public health protection given by the regime. Regulation 3 remedies are not subject to a regime of specific safety or quality requirements. There are no restrictions in terms of those who operate under the regime. Anyone—irrespective of qualifications or experience—can practise herbal medicine and, after making a diagnosis and forming a judgment about the treatment required, can make up and supply an unlicensed herbal medicine.”

As we heard in the debate, there was a great deal of discussion about regulation under the previous Government. They supported moves towards statutory regulation of herbal medicine practitioners, which was the subject of consultation in 2004. The consultation report stated:

“The majority of the responses indicated strong support for the introduction of statutory regulation, in order to ensure patient and public protection and enhance the status of the herbal medicine and acupuncture professions.”—

That point is important in its own right. In 2008, a report to Ministers from the Department of Health steering group on the statutory regulation of practitioners of acupuncture, herbal medicine, traditional Chinese medicine and other traditional medicine systems practised in the UK concluded:

“The Steering Group is strongly of the view that the decision to statutorily regulate professions practising herbal medicine and acupuncture is in the public interest.”

It also urged that there be no Government delay in introducing regulation, saying:

“The Steering Group is of the view that there is an urgent need to proceed without delay with the statutory regulation of practitioners of acupuncture, herbal medicine, traditional Chinese medicine and other traditional medicine systems. The Department of Health has been working with practitioners from these sectors, in some cases for over a decade, and a timeframe has been published that has not been adhered to.”

On 3 August 2009, the four Health Departments of the UK published a consultation paper on statutory regulation of practitioners of acupuncture, herbal medicine, traditional Chinese medicine and other traditional medicine systems practised in the UK. A clear majority of responses—85%—were in favour of statutory regulation, but, as we have heard, there has been little progress, despite the then Secretary of State for Health, the right hon. Member for South Cambridgeshire (Mr Lansley), pledging on 16 February 2011 to regulate herbal medicine practitioners, as the hon. Member for Bosworth pointed out. The Health and Care Professions Council was asked to establish a statutory register for practitioners supplying unlicensed herbal medicines, but there has been no further progress. When does the Minister expect that he will establish a statutory register for practitioners supplying unlicensed herbal medicines? The National Institute of Medical Herbalists is rightly critical of the lack of progress:

“In February 2011, the Secretary of State for Health announced that UK herbalists were to be statutorily regulated. He pledged that, subject to the usual procedures, the Department of Health (DH) would have this ready by 2012. Statutory Regulation (SR) is urgently needed to protect the public from untrained herbalists and also to allow trained herbalists to continue to practice within the constraints of EU Directives. Regulation will be via the Health and Care Professions Council (HCPC) which regulates dentists, dieticians and physiotherapists. Two years later the DH has failed to publish the draft legislation and there is no sign of progress. The fear is that with many other priorities the DH will let the issue drop. Failure to implement SR for herbal medicine practitioners is disastrous…In short, statutory regulation is clearly in the public interest!”

A recent MHRA survey showed that about a quarter of the population use over-the-counter herbal medicines. If that continues, as I suspect it will, surely the Government have a responsibility to ensure that arrangements are in place to make certain that such medicines are safe, as far as they can be, and that those who prescribe and dispense such medicines are appropriately qualified and regulated. It is therefore important that we get a clear view from the Government today on whether they will continue with the statutory registration proposals. It is also important that they give us some confidence that it will be done within a reasonable time frame, so that we can give that confidence back to the industry and those who use herbal medicines.

I commend the hon. Member for Bosworth for his persistence in this matter and for securing the debate today. I look forward to the Minister’s assurances that the Government still take regulation seriously—I hope— and are looking for practical ways to ensure that it can proceed swiftly.